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Innovating LNP design to improve mRNA therapeutics
The new approach involving refinement and optimisation of ionisable lipids could accelerate the development of mRNA therapies, research suggests.
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Drug Safety
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Easing the mental health burden with psychedelic therapies – what’s next for the regulatory and clinical landscape?
In this article, Steffanie Wilson, Vice President and Neuroscience Therapeutic Area Lead, Emmes Group, discusses the future of psychedelic research and highlights the impact of the FDA’s decision on Lykos Therapeutics’ NDA for its MDMA therapy to treat PTSD.
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The future of media hydration: balanced media in automated single-use platforms
By automating and simplifying hydration of media, feeds and buffers, the Oceo Rover system enables manufacturers of biopharmaceuticals to improve process consistency and speed time-to-market. Here, Guy Matthews, Director of Single-Use Technology for FUJIFILM Irvine Scientific, shares more about this transformative hydration solution.
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European Pharmaceutical Review Issue 5 2024
European Pharmaceutical Review Issue 5 includes articles on bioprocessing, biologics, sustainability, and drug formulation.
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Gilead data lends insight into transforming HIV prevention landscape
Results suggest that the small molecule treatment could be an alternative to current medication that aims to prevent HIV infection and which require more frequent dosing.
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First-of-a-kind EU approval granted for eosinophilic esophagitis medicine
With its novel approach for addressing a fundamental cause of eosinophilic esophagitis, approval of the biologic marks a potential new standard of care for paediatric patients.
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Encouraging data revealed for schizophrenia long-acting injectables
Key Phase III and real-world data highlight potential advancements in long-acting injectable treatment options for schizophrenia, Teva and Medincell share.
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Final Chapter <86> text published for early adoption
The Chapter for endotoxin testing using non-animal derived reagents will help quality professionals ensure the safety of sterile pharmaceutical products.
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Trial highlights potential next-gen biologic for lung cancer
Preliminary results from an ongoing trial of a novel monoclonal antibody have confirmed favourable efficacy and safety in recurrent extensive-stage small cell lung cancer (SCLC).
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Developing donanemab – balancing cost versus benefit
This article summarises recent regulatory developments surrounding the Alzheimer’s treatment donanemab and considers the future therapeutic market for this disease.
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Eli Lilly secures MHRA authorisation for Alzheimer’s treatment
Authorisation in Great Britain means eligible Alzheimer's patients can access the treatment, which is part of a new class of amyloid targeting therapies.
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Drug combination shows promise for mitigating microbial biofilms
Combining allicin with domiphen could reduce biofilm formation, providing a potential avenue for overcoming antimicrobial resistance, research suggests.
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Innovating allergy drug delivery with a needle-free alternative
Dr Sarina Tanimoto, MBA, Co-Founder and Chief Medical Officer of ARS Pharmaceuticals, discusses the company’s EURneffy adrenaline nasal spray as a novel, needle-free option to older approved injectables such as intramuscular injection, following its authorisation in the EU and US.
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Digitalisation propelling automated microbiology market growth to 2033
Increased adoption of artificial intelligence (AI) and machine learning (ML) in microbiology is set to be a key driver of the global automated microbiology market to 2033, research asserts.
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Haemophilia treatment with new delivery method approved
The US FDA has authorised the first treatment for haemophilia A or B that is administered via a pre-filled pen or syringe.
